Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W)
Ropack Inc.
BETAINE
BETAINE 1 g in 1 g
ORAL
PRESCRIPTION DRUG
Cystadane ® (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are: - Cystathionine beta-synthase (CBS) deficiency - 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency - Cobalamin cofactor metabolism (cbl) defect None. Pregnancy Category C: Animal reproduction studies have not been conducted with Cystadane. It is also not known whether Cystadane can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystadane should be given to a pregnant woman only if clearly needed. It is not known whether Cystadane is excreted in human milk. Use only if clearly needed. The majority of case studies of homocystinuria patients treated with Cystadane have been pediatric patients, including patients ranging in age from 24 days to 17 years [see Clinical Studies ( 14)]. Children younger than 3 years of age may benefit from dose titration [see Dosag
Cystadane is available in plastic bottles containing 180 grams of betaine anhydrous. Each bottle is equipped with a plastic child-resistant cap and is supplied with a polystyrene measuring scoop. One level scoop (1.7 mL) is equal to 1 gram of betaine anhydrous powder. NDC 52276-400-01 180 g/bottle Store at room temperature, 15 – 30 ˚C (59 – 86 ˚F). Protect from moisture.
New Drug Application
CYSTADANE- BETAINE POWDER, FOR SOLUTION ROPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CYSTADANE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CYSTADANE. CYSTADANE (BETAINE ANHYDROUS FOR ORAL SOLUTION) POWDER INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Cystadane is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are ( 1): Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect DOSAGE AND ADMINISTRATION Usual dose in adult and pediatric patients is 6 grams per day, administered orally in divided doses of 3 grams two times a day. ( 2) In children less than 3 years of age, may initiate dosing at 100 mg/kg/day, divided in twice daily doses, and then increased weekly by 50 mg/kg increments. ( 2) Dose can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts. ( 2) Monitor patient response by plasma homocysteine levels. ( 2) Prescribed amount of Cystadane should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula, or mixed with food for immediate ingestion. ( 2) DOSAGE FORMS AND STRENGTHS Powder for oral solution available in bottles containing 180 grams of betaine anhydrous. ( 3) CONTRAINDICATIONS None ( 4) WARNINGS AND PRECAUTIONS Hypermethioninemia: Cystadane may worsen elevated plasma methionine concentrations in patients with CBS deficiency. Cerebral edema has been reported in patients receiving Cystadane. ( 5.1) Monitoring: Monitor plasma methionine concentrations in patients with CBS deficiency. Keep plasma methionine concentrations below 1,000 µmol/L through dietary modification and, if necessary, a reduction of Cystadane dose. ( 5.1) ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) Preberite celoten dokument